Sanofi/Glaxo to Supply 70M Coronavirus Vaccine Doses in Canada
Sanofi SNY and its partner GlaxoSmithKline GSK announced an agreement with the government of Canada to supply up to 72 million doses of the adjuvanted COVID-19 vaccine that the companies are developing together, if approved. The vaccine will be produced at Glaxo and Sanofi’s manufacturing sites in Canada
Sanofi’s recombinant protein-based technology is being combined with Glaxo’s pandemic adjuvant technology to develop an adjuvanted COVID-19 vaccine.
Earlier this week, the companies signed a confirmed agreement with the European Union to supply up to 300 million doses of the COVID-19 vaccine to European countries. Glaxo and Sanofi also have an advanced purchase agreement for 100 million doses of their COVID-19 vaccine with the U.S. government, which will provide funding of $2.1 billion for the development and manufacturing of the initial 100 million doses. The U.S. government also has an option to purchase an additional 500 million doses.
They also have an agreement (subject to final contract) with the U.K. government to supply up to 60 million doses of the COVID-19 vaccine.
So far this year, Sanofi’s shares have declined 0.7% compared with the industry’s decline of 0.4% in the said time frame.
Earlier this month, Sanofi and Glaxo initiated a phase I/II clinical study on their COVID-19 vaccine candidate, which will enroll 440 healthy adult participants. Data from the pre-clinical studies showed promising safety and immunogenicity of the candidate.
Data from the phase I/II study are expected in December. If this data is positive, then the companies plan to start a phase III study by the end of year and file for regulatory approval in the first half of 2021. The companies plan to produce 1 billion doses of the adjuvant vaccine in 2021.
Sanofi has a separate a collaboration with Translate Bio TBIO to jointly develop a novel messenger RNA (mRNA) vaccine for COVID-19. A phase I/II study is expected to start in November. However, Sanofi and Regeneron’s REGN immunology drug, Kevzara failed to show benefit in clinical studies evaluating it as a possible treatment for hospitalized patients with severe/critical COVID-19.
In a separate press release, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of its quadrivalent recombinant influenza vaccine, Supemtek. The vaccine has been available in the United States with the brand name of Flublok since 2017. The European Commission’s (EC) decision is expected in the fourth quarter. Supemtek has been developed leveraging Sanofi’s recombinant manufacturing technology, which is the same technology being used to develop Sanofi and Glaxo’s COVID-19 vaccine candidate.
The CHMP also recommended approval of MenQuadfi, Sanofi’s meningococcal vaccine for active immunization of individuals (12 months and older) against invasive meningococcal ACWY disease. MenQuadfi was approved in the United States in April. The EC’s decision is expected before the end of the year.
Sanofi has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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